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Announcement

BioDiem/Opal Biosciences Investor presentation at Wholesale Investor

Melbourne, 26 February 2016: BioDiem’s CEO, Julie Phillips presented at the Wholesale Investor Life Science &Healthcare Showcase, held at ASX Offices, Exchange Centre in Sydney on 25th February 2016. The event targeted investors and included life science and healthcare companies. The BioDiem/Opal presentation focused on BioDiem’s revenue-generating LAIV Vaccine program, and its antimicrobial BDM-I, which is being commercialised through BioDiem’s subsidiary, Opal Biosciences.

- ENDS - About BioDiem Ltd BioDiem is an Australian biopharmaceutical company that is focused on developing and commercialising vaccines and infectious disease therapies. BioDiem’s business model is to generate income from partnerships including with other vaccine and infectious disease treatment companies through existing and new licences to its LAIV vaccine and other technologies. Income comes from licence fees and royalties on sales. BioDiem’s lead technology is the LAIV (Live Attenuated Influenza Virus) vaccine technology used for production of seasonal and pandemic influenza vaccines and is given intranasally. This technology is licensed currently to two commercial partners, in India and China, and is licenced to the World Health Organisation as part of the Global Pandemic Influenza Action Plan to Increase Vaccine Supply. Serum Institute of India’s Nasovac-S™ is based on BioDiem’s technology and is already marketed in India. BioDiem’s antimicrobial technology, BDM-I, is being developed through its subsidiary, Opal Biosciences Ltd. For additional information, please visit www.biodiem.com. About Opal Biosciences Ltd Opal Biosciences is an Australian biotechnology company and an innovative player in infectious disease treatment. The unmet need for new anti-infectives is due to increasing resistance to existing antibiotics, more widespread and common difficult-to-treat infections, and the paucity of upcoming new treatments. This need has spurred the EU and US to introduce significant financial incentives to encourage development of new anti-infectives. Opal is currently seeking funding to support the next stage of development of our products:

• Opal-I, an injectable product, and • Opal-T, which can be applied to the skin.

For more information, please visit www.opalbiosciences.com.

BIODIEM LTD ABN 20 096 845 993

Level 4, 100 Albert Rd, South Melbourne, Victoria, 3205 Australia Phone: +613 9692 7240 Web: www.biodiem.com

Therapies and vaccines for infectious diseases

Julie  Phillips,  CEO  

@biodiem  @opalbiosciences  

Wholesale Investor

Life Science & Healthcare Showcase 25 February 2016

   This  presenta3on  is  provided  to  you  for  informa3on  purposes  only  and  should  not  be  

construed  as  an  offer,  and  shall  not  form  part  of  an  offer,  or  solicita3on  to  buy  or  sell  any  securi3es  or  deriva3ves.  It  should  not  be  considered  as  an  invita3on  to  subscribe  for  or  purchase  any  securi3es  in  BioDiem  Limited.  or  as  an  inducement  to  make  an  offer  or  invita3on  with  respect  to  those  securi3es.  No  agreement  to  subscribe  for  securi3es  in  

BioDiem  Limited  will  be  entered  into  on  the  basis  of  this  presenta3on.      

To  the  maximum  extent  permiDed  by  applicable  laws,  BioDiem  Limited  and  its  affiliates  make  no  representa3on  and  can  give  no  assurance,  guarantee  or  warranty,  express  or  

implied,  as  to,  and  take  no  responsibility  for  the  authen3city,  validity,  accuracy,  suitability  or  completeness  of,  or  any  errors  in  or  omission,  from  any  informa3on,  statement  or  

opinion  contained  in  this  presenta3on.      

The  contents  of  this  presenta3on  are  confiden3al.  The  presenta3on  is  being  provided  to  you  on  the  condi3on  that  you  do  not  reproduce  or  communicate  it  to,  or  disclose  it  to,  or  discuss  it  with,  any  other  person  without  the  prior  wriDen  permission  of  BioDiem  Limited.    

 

Safe  Harbour  Statement  

Challenges  

Increasing  resistance  To  an3bio3cs  –  major  concern  healthcare  systems  worldwide  

No  Rx  available  -­‐totally  resistant  tuberculosis  -­‐totally  resistant  gonorrhoea    

Hard  to  treat  Fungal  infec3ons,  affec3ng  vulnerable  pa3ents  

Product  pipelines  diminish  Large  Pharma  moved  away  from  an3-­‐infec3ve  research  

Influenza  vaccines  (seasonal  and  pandemic)    Pandemic  =  new  emerging  flu  virus;  low  popula6on  immunity  

Core  development  programs  

LAIV  vaccine  –  licensed  in  mul3ple      countries  

Infec3ous  disease  therapies  (for  hard-­‐to-­‐treat  and  serious  Infec3ons)  

Target   Core  Technology  

Influenza Vaccines

LAIV  -­‐  nasal  spray  to  prevent  ‘flu  

Needle-­‐free  nasal  delivery  No  trained  personnel  and  blood/sharps  precau3ons  unnecessary  

Extensive  clinical  and  market  experience  >  100m  doses  In  Russia  efficacy  and  safety  in  >500,000  adults/140,000  children  

High  yields  In  egg-­‐based  or  cell-­‐based  produc3on  (with  no  reliance  on  eggs)  

No  adjuvant  required  

Broader  immune  response  Than  seen  with  inac3vated  influenza  vaccines  

Influenza vaccines

Live  AOenuated  Influenza  Virus:  LAIV  Disease Targets

Current Partners

Development Status

WHO SII (India) BCHT (China) IEM (Russia)

•  Marketed •  License revenues FY15 $180,000   Growth through sales &new licences

IEM/WHO

Clinical trials completed in •  Thailand & •  Russia Avian flu library tested in ferrets & FIH trials (stored at CDC, Atlanta)

LAIV Influenza vaccine - India

Nasovac-S – seasonal influenza vaccine

•  Produced by Serum Institute of India

•  Marketed in India

•  Distributed by Cipla (May 2015)

•  WHO prequalification (October 2015)

•  Royalties to BioDiem

Changchun BCHT Biotechnology Co

* Clinical trials to commence 2016 *

LAIV Influenza vaccine - China

Studies on seasonal trivalent LAIV  

Influenza  vaccines  (seasonal  and  pandemic)    Pandemic  =  new  emerging  flu  virus;  low  popula6on  immunity  

Core  development  programs  

LAIV  vaccine  –  licensed  in  mul3ple      countries  

Infec3ous  disease  therapies  (for  hard-­‐to-­‐treat  and  serious  Infec3ons)  

Target   Core  Technology  

INTRODUCING OPAL TECHNOLOGY!

•  SelecSve  acSvity  shown  against  important  human  pathogens,  incl.  resistant  bacterial  and  fungal  

•  Currently  selected  for  three  US  programs  (NIH  &  USAMRIID)-­‐  drug-­‐resistant  TB,  Pneumocys3s  spp,  F.  tularensis.  

•  Poten3al  for  various  routes  of  administra3on.  •  Currently  seed  capital  raising  for  proof-­‐of-­‐concept  in  vivo.  

Drug  resistant  Tuberculosis*  (TB)  

*These  projects  have  been  funded  with  Federal  funds  from  the  NIH/NIAID/DMID    **  Contract  No.  HHSN272201100012I  ***  Contract  No.  HHSN272201100018I    ****  Contract  No.  HHSN272201000029I  /  HHSN27200002  /A51    #This  project  has  been  supported  by  the  U.S.  Army  Medical  Research  Ins3tute  of  infec3ous  Diseases  (USAMRIID)  under  its  Material  Transfer  Agreement  (MTA)  with  BioDiem  Ltd      

Pneumocys8s  

Biowarfare  target  

USAMRIID#    

NIAID*  

NIAID*   In  vitro    screening  

Extended  In    vitro  screening**  

In  vivo    tes3ng  

Extended  In    vitro  screening***  

In  vivo  tes3ng  ****  

In  vivo    tes3ng  

NIAID/USAMRIID PROGRAMS

In  vitro    screening  

In  vitro    screening  

POTENTIAL PRODUCT LINE

Topical  Use  (Gel,  ointment,  spray)  Intravenous  Use  (InjecSon)  

Oral  Use  (Tablets,  capsules,  syrup,  mouthwash)  

Lung  (InhalaSon)  

GLOBAL COLLABORATIONS!

The  Opal  Technology  project  brings  together  a    wealth  of  internaSonal  experSse.      

           

 hDp://www.niaid.nih.gov/LabsAndResources/resources/dmid/invitro/Pages/invitro.aspx  

hDp://www.niaid.nih.gov/labsandresources/resources/dmid/animalmodels/Pages/default.aspx  

OPAL’S DEVELOPMENT TIMELINE !( Indicative )

THE MARKET !

Ref:  Global  An3fungal  Therapeu3cs  Market:  Trends  and  Opportuni3es  (2014-­‐2019)  Daedal  Research,  August  2014  An3-­‐infec3ves  –  A  Global  Strategic  Business  Report,  Global  Industry  Analysts,  Inc.  MCP-­‐6156,  February,  2010.    An3bacterial  Drugs  Market-­‐  A  Global  Industry  Analysis,  Size,  Share,  Growth,  trends  and  Forecast,  2013-­‐2019,    Transparency  Market  Research,  March  2014.    

Merck  to  Buy  Cubist  for    $8.4  Billion  to  Add  An3bio3cs  

Roche  inks  $750M  anSbioSc    pact  with  Meiji  and  Fedora  

AnSfungals    market,    US$13.9b  

AnSbacterials  market,  US$46b  

by  2019  

AnS-­‐infecSves  market,  US$103b  

by  2015    

US GOVERNMENT INCENTIVES!

1.   The  GAIN  (GeneraSng  AnSbioSc  IncenSves  Now)  LegislaSon  2.   FDA’s  Priority  Review:  FDA’s  goal  is  to  take  ac3on  on  an  

applica3on  within  6mths  (compared  to  10mths).  

3.   Orphan  Drug  DesignaSon:  Sponsor  of  the  drug  en3tled  to  development  incen3ves  (tax  credits,  extended  market  exclusivity).  

4.   FDA’s  Fast  Track  Process:  Designed  to  facilitate  the  development,  and  expedite  the  review  of  much  needed  new  treatments.  

Why  invest  in  BioDiem?  

•  BioDiem has successfully licensed its flu vaccine into the largest markets in the world.

•  A proven track record of license growth, e.g. BCHT (China) and the Serum Institute of India.

•  Exposure to multiple exciting opportunities for disease treatments with high market need.

•  Global partnering strategy with research leaders accelerates development and delivers more for each research and development dollar.

•  Exposure to

•  Revenue growth with a commercial technology; and

•  High potential earlier stage anti-infective, Opal Biosciences Ltd.

Therapies and vaccines for infectious diseases

Julie  Phillips,  CEO  jphillips@biodiem.com  

Wholesale Investor

Life Science & Healthcare Showcase 25 February 2016